FDA grants priority review to Boehringer’s BI 1810631 for the treatment of HER2-mutant advanced NSCLC

Rick and Mary Pazdur on facing “the other side of the stethoscope”
A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology

The Pazdurs in their garden with their dog, Cleo. The dog’s full name is Cleopatra, Queen of Denial.In 1999, Rick Pazdur went in for a “perfunctory” final interview at FDA. Thinking it would only take a few minutes, his wife, Mary, decided to wait and have a quick cup of coffee at a nearby restaurant—Hooters.

In the name of “radical transparency,” FDA touts publication of 200 complete response letters

In a move advertised as being in line with FDA’s goal of “radical transparency,” the agency July 10 announced the publication of more than 200 complete response letters.

Arjan Gower receives NCCN grant to study a targeted therapy for early-stage NSCLC with rare EGFR mutations

Arjan Gower, a hematologist/oncologist at the UCLA Health Jonsson Comprehensive Cancer Center, received a $950,000 grant from the National Comprehensive Cancer Network and Taiho Oncology Inc. to help launch a multi-institutional clinical trial to test zipalertinib, an investigational drug that targets specific EGFR mutations, including Exon 20 insertions, which are known to drive cancer growth and resist standard treatments.

July 11, 2025

Vol.51 No.27

Clinical Roundup

Steroids may make immunotherapy less effective for lung cancer patients, retrospective study finds

Corticosteroids, a commonly prescribed medication to alleviate cancer-related symptoms for non-small cell lung cancer patients treated with immunotherapy, are the main reason certain immunotherapies may fail in treating the disease, according to research led by researchers at Keck Medicine of USC.

July 11, 2025

Vol.51 No.27

Drugs & Targets

FDA grants accelerated approval to Zegfrovy for NSCLC with EGFR exon20ins

FDA has approved Zegfrovy (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

July 03, 2025

Vol.51 No.26

Drugs & Targets

FDA grants accelerated approval to linvoseltamab-gcpt for r/r MM

FDA has granted accelerated approval to linvoseltamab-gcpt, trade name Lynozyfic, a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

July 03, 2025

Vol.51 No.26

FDA grants priority review to Boehringer’s BI 1810631 for the treatment of HER2-mutant advanced NSCLC

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Rick and Mary Pazdur on facing “the other side of the stethoscope”
A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology

In the name of “radical transparency,” FDA touts publication of 200 complete response letters

Arjan Gower receives NCCN grant to study a targeted therapy for early-stage NSCLC with rare EGFR mutations

Steroids may make immunotherapy less effective for lung cancer patients, retrospective study finds

FDA grants accelerated approval to Zegfrovy for NSCLC with EGFR exon20ins

FDA grants accelerated approval to linvoseltamab-gcpt for r/r MM

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FDA grants priority review to Boehringer’s BI 1810631 for the treatment of HER2-mutant advanced NSCLC

YOU MAY BE INTERESTED IN

Rick and Mary Pazdur on facing “the other side of the stethoscope”A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology

In the name of “radical transparency,” FDA touts publication of 200 complete response letters

Arjan Gower receives NCCN grant to study a targeted therapy for early-stage NSCLC with rare EGFR mutations

Steroids may make immunotherapy less effective for lung cancer patients, retrospective study finds

FDA grants accelerated approval to Zegfrovy for NSCLC with EGFR exon20ins

FDA grants accelerated approval to linvoseltamab-gcpt for r/r MM

Never miss an issue!

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Rick and Mary Pazdur on facing “the other side of the stethoscope”
A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology